comprehensive site management
Optimus Clinical Research provides end-to-end site management services for clinical trials, ensuring excellence at every stage. From meticulous site selection and feasibility studies to comprehensive site initiation, monitoring, and compliance, we ensure trials are conducted seamlessly. Our expertise guarantees proper site closeout with full compliance, safeguarding data integrity and regulatory adherence.
Site Selection & Feasibility
- Conduct feasibility studies to assess site capability based on trial requirements.
- Evaluate site’s ability to recruit patients, infrastructure, and previous trial experience.
- Identify suitable sites based on geographic location, patient demographics, and site performance.
Site Initiation & Setup
- Assist in site setup, including infrastructure development and regulatory approval.
- Provide trial-specific training and team onboarding.
- Coordinate the installation of required equipment, equipment maintenance and calibration.
Site Monitoring & Compliance
- Monitor patient recruitment, retention, and data quality to maintain trial integrity.
- Ensure compliance with Good Clinical Practice (GCP), regulatory standards, and ethical guidelines.
- Resolve any issues or deviations through corrective actions and ongoing support.
Site Closeout
- Ensure the proper closure of the trial site after data collection and the completion of study objectives.
- Conduct final site visits to ensure all clinical trial documentation, data, and materials are properly stored and secured.
- Complete final reconciliation of investigational products, supplies, and inventory.
- Ensure that all required documentation is completed, including regulatory filings, site-specific reports, and closeout letters.
